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临床试验/CTRI/2018/04/013178
CTRI/2018/04/013178已完成不适用

Efficacy of transcranial direct current stimulation (tDCS) on upper limb motor control in persons with sub-acute stroke - A randomized controlled trial

D Subramanian1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
1. kinematic Analysis ( reach-to-grasp standardized Test Task)

研究概览

简要总结

Residual upper limb paresis is one of the most common motor impairments that affect stroke survivor’s activities of daily living. Upper limb reaching movement, a necessary component for performing many tasks of daily living is affected in stroke. Reaching movement in survivors with stroke is characterized by abnormal patterns of muscle activation and limitation in joint ranges. These abnormal patterns of muscle activation and limitation in joint ranges may be due to deficits in the range of regulation of tonic stretch reflex thresholds (TSRT) of agonist and antagonist muscles. TSRT is the joint angle at which motorneuronal recruitment begins. Although various physical therapy approaches improves effective use of the arm including reaching, residual reaching movement deficits persist in persons with stroke.

Transcranial direct current stimulation (tDCS), a non-invasive method of brain stimulation helps in enhancing neural plasticity and learning through neuromodulation and by increasing neurotransmitter, receptor and neurotrophin levels. Based on its effects on neural plasticity and learning, we hypothesize that, tDCS combined with upper limb reaching training could improve reaching ability in stroke persons by altering the spatial zones.Hence, the aim of this study is to determine the efficacy of tDCS on upper limb motor control in persons with sub-acute stroke.

This study is a double blinded randomized controlled trial. The participants in the intervention group will receive anodal tDCS along with task specific training with trunk restraint (TRTST) and the control group will receive sham tDCS along with TRTST. Both groups will receive either anode or sham tDCS in the first 30 minutes of a one hour of TRTST session per day for 5 days per week for 4 consecutive weeks. The primary outcome measures are kinematic analysis of elbow extension range during a standardized reach-to-grasp task, Spatial zones such as coactivation zone and silent zone of both agonist and antagonist using Montreal TSRT measure, Chedoke Arm and Hand Activity Inventory (CAHAI- 7 Version) and Action Research Arm Test (ARAT) and secondary measures are Reaching Performance Scale, composite spasticity Index, Upper Extremity Subset of Fugl – Meyer Motor Function Assessment (UE –FMA), Patient Health Questionnaire-9. Both primary and secondary outcome measures will be taken before the first day of the intervention, immediately after the 4 weeks of intervention and after a 1 month follow up period.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Medically stable participants
  • Cortical or subcortical area lesion supplied by middle cerebral artery, Anterior cerebral artery, Posterior cerebral artery and confirmed by MRI / CT
  • Early or late subacute stage (1- 6 months)
  • Ischemic or hemorrhagic stroke
  • Arm paresis with Chedoke McMaster Arm Score of 2-6 out of 7 and Hand score of 2-6 out of
  • Recurrent stroke with completely recovered previous stroke.

排除标准

  • Major neurological (other than stroke) / neuromuscular / orthopaedic problems 2.Major cognitive deficits 3.History of psychiatric disorders,seizure, migraine within last six months
  • Metal in cranium and other implants (cochlear, cardiac)
  • Skin sensitivity
  • Participants taking medications that could affect brain activity (e.g. epileptic and psychoactive drugs).

结局指标

主要结局

1. kinematic Analysis ( reach-to-grasp standardized Test Task)

时间窗: 0 weeks, 4 weeks and 8 weeks

2. Montreal Tonic stretch threshold measure (Spatial zones)

时间窗: 0 weeks, 4 weeks and 8 weeks

3. Chedoke Arm and Hand Activity Inventory (CAHAI- 7 Version)

时间窗: 0 weeks, 4 weeks and 8 weeks

4. Action Research Arm Test (ARAT)

时间窗: 0 weeks, 4 weeks and 8 weeks

次要结局

  • 1. Reaching Performance Scale(2. Composite spasticity Index)

研究者

发起方
D Subramanian
申办方类型
Other [Principal Investigator]

研究点 (1)

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